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MGD007+ MGA012

Phase 1

Colorectal Cancer Metastatic | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Feb 8, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

MGD007+ MGA012 · 1 trial · 1 indication

Phase 1 1
NCT03531632MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal CancerColorectal Cancer Metastatic
COMPLETED38 Analytics
PHASE1COMPLETED
MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer
Colorectal Cancer MetastaticUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events
Up to approximately 12 weeks

Adverse Events, Serious Adverse Events

Secondary Endpoints

Peak Plasma Concentration
7 weeks
Number of Participants That Develop Anti-drug Antibodies
1 year
The Number of Participants With Response Based on the Change in Tumor Volume
Every 8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MGD007 + MGA012EXPERIMENTALMGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody.

Interventions

NameTypeDescription
MGD007 + MGA012BIOLOGICALMGD007 and MGA012 are administered by IV infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Histologically proven, relapsed/refractory metastatic colorectal cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Measurable disease per RECIST 1.1 criteria * Participants in the Dose Escalation Phase must have had recurrence, progression or intol...

Countries:United States
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Competitive Landscape -Colorectal Cancer 258 trials (matched to "Colorectal Cancer Metastatic")

Frequently asked questions about MGD007+ MGA012

What is MGD007 used for?

MGD007 is an investigational oncology drug being studied for the treatment of colorectal carcinoma and metastatic colorectal cancer. It has been evaluated in patients with relapsed or refractory disease, meaning cancer that has returned or not responded to prior treatments. The drug is currently in clinical development and is not approved by regulatory authorities.

Who makes MGD007?

MGD007 is being developed by MacroGenics, Inc., a biopharmaceutical company. MacroGenics is publicly traded on the NASDAQ under the ticker symbol MGNX. The company is conducting clinical trials to evaluate the safety and efficacy of MGD007 in patients with colorectal cancer.

What phase is MGD007 in?

MGD007 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one studying MGD007 as a monotherapy and another studying it in combination with MGA012. The drug remains investigational and has not received FDA approval for any indication.

What clinical trials is MGD007 in?

MGD007 has been studied in two completed Phase 1 clinical trials. The first, NCT02248805, evaluated MGD007 alone in patients with relapsed or refractory metastatic colorectal carcinoma. The second, NCT03531632, studied MGD007 in combination with MGA012 in patients with relapsed or refractory metastatic colorectal cancer. Both trials were conducted in the United States.

Is MGD007 the same as MGA012?

No, MGD007 and MGA012 are different investigational drugs. MGD007 is being studied as a monotherapy and in combination with MGA012. A completed Phase 1 trial, NCT03531632, evaluated the combination of MGD007 and MGA012 in patients with relapsed or refractory metastatic colorectal cancer.